Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity: the ReCharge randomized clinical trial.

IMPORTANCE: Although conventional bariatric surgery results in weight loss, it does so with potential short-term and long-term morbidity. OBJECTIVE: To evaluate the effectiveness and safety of intermittent, reversible vagal nerve blockade therapy for obesity treatment. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, sham-controlled clinical trial involving 239 participants who had a body mass index of 40 to 45 or 35 to 40 and 1 or more obesity-related condition was conducted at 10 sites in the United States and Australia between May and December 2011. The 12-month blinded portion of the 5-year study was completed in January 2013. INTERVENTIONS: One hundred sixty-two patients received an active vagal nerve block device and 77 received a sham device. All participants received weight management education. MAIN OUTCOMES AND MEASURES: The coprimary efficacy objectives were to determine whether the vagal nerve block was superior in mean percentage excess weight loss to sham by a 10-point margin with at least 55% of patients in the vagal block group achieving a 20% loss and 45% achieving a 25% loss. The primary safety objective was to determine whether the rate of serious adverse events related to device, procedure, or therapy in the vagal block group was less than 15%. RESULTS: In the intent-to-treat analysis, the vagal nerve block group had a mean 24.4% excess weight loss (9.2% of their initial body weight loss) vs 15.9% excess weight loss (6.0% initial body weight loss) in the sham group. The mean difference in the percentage of the excess weight loss between groups was 8.5 percentage points (95% CI, 3.1-13.9), which did not meet the 10-point target (P = .71), although weight loss was statistically greater in the vagal nerve block group (P = .002 for treatment difference in a post hoc analysis). At 12 months, 52% of patients in the vagal nerve block group achieved 20% or more excess weight loss and 38% achieved 25% or more excess weight loss vs 32% in the sham group who achieved 20% or more loss and 23% who achieved 25% or more loss. The device, procedure, or therapy-related serious adverse event rate in the vagal nerve block group was 3.7% (95% CI, 1.4%-7.9%), significantly lower than the 15% goal. The adverse events more frequent in the vagal nerve block group were heartburn or dyspepsia and abdominal pain attributed to therapy; all were reported as mild or moderate in severity. CONCLUSION AND RELEVANCE: Among patients with morbid obesity, the use of vagal nerve block therapy compared with a sham control device did not meet either of the prespecified coprimary efficacy objectives, although weight loss in the vagal block group was statistically greater than in the sham device group. The treatment was well tolerated, having met the primary safety objective. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01327976.

24-Month results of the BRAVO study: A prospective, multi-center study evaluating the clinical outcomes of a ventral hernia cohort treated with OviTex® 1S permanent reinforced tissue matrix.

Background: This study evaluated the performance of OviTex® 1S (TELA Bio Inc., Malvern, PA, USA) over 24 months when used for ventral hernia repair. Methods: This was a prospective, single-arm, multi-center clinical trial (ClinicalTrials.gov/NCT03074474). A ninety-two patient cohort with ventral hernias were enrolled. The surgical approach (open, laparoscopic, or robotic) and plane of placement (retrorectus, intraperitoneal, or pre-peritoneal) were at the discretion of the surgeon. Patients were characterized as high risk for a surgical site occurrence (SSO) based on the following comorbidities: BMI between 30 and 40, active smoker, chronic obstructive pulmonary disease (COPD), diabetes mellitus, coronary artery disease, advanced age ( ≥ 75 years). Subjects underwent physical examinations to evaluate safety events and completed quality of life surveys at 1 months, 3 months, 12 months, and 24 months post-surgery. Results: Sixty-five of the 92 enrolled patients (70.7%) completed 24-month follow-up. The Kaplan Meier estimate for risk of recurrence at day 730 (24 months) was 2.6%; among subjects who completed their 24-month visit or had a previous recurrence, the unadjusted rate of recurrence was 4.5% (3/66). SSOs were observed in 38.0% of patients (35/92). The most prevalent SSO was surgical site infection occurring in 20.7% (19/92) of patients, followed by seroma formation, which occurred in 13.0% of patients; however, only 3.3% required intervention. HerQLes and EQ-5D assessments showed improvement from baseline as soon as 3 months post-surgery. Continued improvement was observed through 24 months. Conclusions: Overall the BRAVO study demonstrates that use of the ovine reinforced tissue matrix OviTex 1S is a viable option for use in ventral hernia repair. Additional studies with longer term follow-up data are needed to draw definitive conclusions on the use of OviTex 1S.

A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex® 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis.

BACKGROUND: Conflicting results from previous studies have led to dissent over whether surgical mesh is safe and effective in ventral hernia repair. A newer class of mesh known as a reinforced tissue matrix, combining a biologic scaffold and minimal polymer reinforcement, offers promise in reducing inflammatory response and increasing abdominal wall support. This study sought to assess the clinical utility of a reinforced tissue matrix (OviTex) in ventral hernia repair 12 months after implantation. METHODS: This is a prospective, single-arm, multi-center study to evaluate the clinical performance of OviTex® 1S Permanent (OviTex) in the repair of primary or recurrent ventral hernias (VH) in consecutive patients (ClinicalTrials.gov/NCT03074474). The rate of surgical site occurrences (SSOs) was evaluated 90 days post-surgery as the primary endpoint. Hernia recurrence and the incidence of postoperative events were evaluated between three and 12 months as secondary endpoints. The incidence of other complications and patient-reported outcomes were also recorded. RESULTS: Ninety-two (92) patients were enrolled in the study, of whom seventy-six (76) reached the 12-month follow-up. All patients were at least 18 years of age with a BMI of <40 kg/m2. Hernia defects were <20 × 20 cm, classified as class I-III according to the CDC wound classification system. Of the 76 patients who reached 12-month follow-up, twenty-six (34%) had previous VH repairs and thirteen (17%) had previous surgical infection. Sixty (79%) had factors known to increase the risk of recurrence. Twenty patients (26%) experienced SSOs, with ten (13%) requiring procedural intervention. Two of the 75 patients (2.7%) experienced a recurrence. CONCLUSIONS: The low rate of hernia recurrence and SSOs requiring intervention illustrates the potential that reinforced tissue matrices, and OviTex 1S, in particular, have to improve outcomes in VH repairs. Follow-up to 24 months is ongoing.

Endoscopic and surgical treatments for achalasia: a systematic review and meta-analysis.

BACKGROUND: Although rare, esophageal achalasia is the best described primary esophageal motility disorder. Commonly used treatments are endoscopic botulin toxin injection (EBTI), endoscopic balloon dilation (EBD), and surgical myotomy with or without a fundoplication; however, reported outcomes mostly come from cohort studies. OBJECTIVE: To summarize and compare the safety and efficacy of endoscopic and surgical treatments for esophageal achalasia. METHODS: A systematic electronic Medline literature search of articles on esophageal achalasia. Treatment options reviewed included EBTI, EBD, and surgical myotomy using open and minimally invasive techniques. Main outcome measures were frequency of symptom relief, prevalence of post-treatment gastroesophageal reflux (GER), and complications. Outcome probability was estimated using weighted averages of the sample prevalence in each study, with weights equal to the number of patients. Outcomes, within or across studies, were compared using meta-analysis and meta-regression, respectively. RESULTS: A total of 105 articles reporting on 7855 patients were selected, tabulated and reviewed. Symptom relief after EBD was better than after EBTI (68.2% vs. 40.6%; OR 3.4; 95% CI, 1.2-9.8; P = 0.02), and the need for additional therapy was greater for patients receiving EBTI (46.6% vs. 25%; OR, 2.6; 95% CI, 1.05-6.5; P = 0.04). Laparoscopic myotomy, when combined with an antireflux procedure, provided better symptom relief (90%) than all endoscopic and other surgical approaches and a low complication rate (6.3%). The incidence of postoperative GER was lower when a fundoplication was added to a laparoscopic myotomy (31.5% without a fundoplication vs. 8.8% with; OR, 6.3; 95% CI, 2.0-19.4; P = 0.003). CONCLUSIONS: EBD is superior to EBTI. Laparoscopic myotomy with fundoplication was the most effective surgical technique and can be considered the operative procedure of choice.

The impact of roux limb length on weight loss after gastric bypass.

BACKGROUND: Extending the length of the Roux limb (RL) in gastric bypass (GBP) may improve weight loss in super obese patients (body mass index [BMI] > 50 kg/m(2)), but no consensus exists about the optimal length of the RL. We sought to determine the impact of RL length on weight loss in super obese patients 1 year after GBP. MATERIALS AND METHODS: One-year weight loss outcomes were analyzed in all super obese patients who underwent consecutive and primary laparoscopic or open GBP between January 2003 and June 2006. Patients were divided into two groups according to RL length (100 vs. 150 cm). The RL length was at the discretion of the attending surgeon. Baseline and follow-up data were collected prospectively. Multiple linear regression was used to adjust for potential confounders in the weight loss outcomes. RESULTS: Twelve-month follow-up data were available in 137 (85%) of 161 patients with a BMI >or= 50 who underwent GBP during the study period. An RL of 100 or 150 cm was used in 102 (74.5%) and 35 patients (25.5%), respectively. In multivariate analysis, patients with the 150-cm RL lost more weight (68.5 vs. 55.3 kg, p < 0.01), had a greater change in BMI (25 vs. 21 kg/m(2), p = 0.01), and had greater excess weight loss (64 vs. 53%, p < 0.01). CONCLUSION: A 150-cm RL provides better weight loss outcomes in super obese patients at 1-year follow-up.

Laparoscopic inguinal hernia repair.

The safest and most effective inguinal hernia repair (laparoscopic versus open mesh) is being debated. As the authors point out, the former accounts for the minority of hernia repairs performed in the United States and around the world. The reasons for this are a demonstration in the literature of increased operative times, increased costs, and a longer learning curve. But the laparoscopic approach has clear advantages, including less acute and chronic postoperative pain, shorter convalescence, and earlier return to work. This article describes the transabdominal preperitoneal and totally extraperitoneal techniques, provides indications and contraindications for laparoscopic repair, discusses the advantages and disadvantages of each technique, and provides an overview of the literature comparing tension-free open and laparoscopic inguinal hernia repair.

Laparoscopic bariatric surgery improves candidacy in morbidly obese patients awaiting transplantation.

BACKGROUND: To evaluate, at a university tertiary referral center, the safety and efficacy of laparoscopic Roux-en-Y gastric bypass (LRYGB) in patients with end-stage renal disease (ESRD) and laparoscopic sleeve gastrectomy (LSG) in patients with cirrhosis or end-stage lung disease (ESLD); and to determine whether these procedures help patients become better candidates for transplantation. METHODS: A retrospective review was performed of selected patients with end-stage organ failure who were not eligible for transplantation because of morbid obesity who underwent LRYGB or LSG. The prospectively collected data included demographics, operative details, complications, percentage of excess weight loss, postoperative laboratory data, and status of transplant candidacy. RESULTS: Of the 15 patients, 7 with ESRD underwent LRYGB and 6 with cirrhosis and 2 with ESLD underwent LSG. Complications developed in 2 patients (both with cirrhosis); no patient died. The mean follow-up was 12.4 months, and the mean percentage of excess weight loss at > or =9 months was 61% (ESRD), 33% (cirrhosis), and 61.5% (ESLD). Obesity-associated co-morbidities improved or resolved in all patients. Serum albumin and other nutritional parameters at > or =9 months after surgery were similar to the preoperative levels in all 3 groups. At the most recent follow-up visit, 14 (93%) of 15 patients had reached our institution's body mass index limit for transplantation and were awaiting transplantation; 1 patient with ESLD underwent successful lung transplant. CONCLUSION: The results of this pilot study have provided preliminary evidence that LRYGB in patients with ESRD and LSG in patients with cirrhosis or ESLD is safe, well-tolerated, and improves their candidacy for transplantation.

Euglycaemic diabetic ketoacidosis in bariatric surgery patients with type 2 diabetes taking canagliflozin.

A 52-year-old type 2 diabetic man previously on canagliflozin developed severe anion gap metabolic acidosis and markedly elevated beta-hydroxybutyrate on postoperative day (POD) 2 status post laparoscopic Roux-en-Y gastric bypass. An insulin drip and aggressive intravenous fluid repletion were initiated, and electrolytes were monitored and repleted. His anion gap closed, and he was discharged on POD 4. This euglycaemic diabetic ketoacidosis prolonged his hospital stay by 2 days.

Predictors, treatment, and outcomes of gastrojejunostomy stricture after gastric bypass for morbid obesity.

BACKGROUND: The aims of this study were to determine the rate of gastrojejunostomy (GJ) stricture following Roux-en-Y gastric bypass (RYGBP), the independent predictors of stricture, and clinical outcomes with and without a stricture. METHODS: Univariate and multivariate analysis of peri-operative and outcomes data were prospectively collected from 379 morbidly obese patients who underwent consecutive open or laparoscopic RYGBP from January 2003 to August 2006. Predictors studied were age, gender, BMI, co-morbidities, surgical technique (hand-sewn vs linear stapler vs 21-mm vs 25-mm circular stapler; open vs laparoscopic; retrocolic retrogastric vs antecolic antegastric Roux limb course, and Roux limb length), and surgeon experience. Outcomes studied consisted of occurrence of GJ strictures, technical details and outcomes after endoscopic therapy, and excess weight loss (EWL) at 12 months. RESULTS: 15 patients (4.1%) developed a GJ stricture. The use of a 21-mm circular stapler was identified as the only independent predictor of a GJ stricture (odds ratio 11.3; 95% CI 2.2-57.4, P = 0.004). Endoscopic dilation relieved stricture symptoms in all patients (60% one dilation only). There was no significant difference in %EWL at 12 months between the patients with a stricture (median EWL 54%, IQR 49-63) vs. those without a stricture (median EWL 61%, ent predictor of GJ stricture. Endoscopic dilation relieved symptoms in all patients. Weight loss is independent of the anastomotic technique used and occurrence of a GJ stricture.

Spectrum and risk factors of complications after gastric bypass.

OBJECTIVE: To study the spectrum of and risk factors for complications after gastric bypass (GBP). DESIGN: Prospective cohort study. SETTING: Academic tertiary referral center. PATIENTS: All morbidly obese patients who underwent open or laparoscopic GBP between January 2003 and December 2006. MAIN OUTCOME MEASURES: Complications were stratified by grade: grade I, only bedside procedure; grade II, therapeutic intervention but without lasting disability; grade III, irreversible deficits; and grade IV, death. Data were analyzed using logistic regression to identify independent risk factors of complications after GBP. Predictors investigated were age, race, sex, marital and insurance status, body mass index, obesity-associated comorbidities, American Society of Anesthesiologists Physical Status Class, operating room time, open or laparoscopic approach, and surgeon experience. RESULTS: Of the 404 morbidly obese patients who underwent consecutive open (n = 72) or laparoscopic (n = 332) GBP, 74 (18.3%) experienced 107 complications. Grade I and II complications were more frequent after open GBP (grade I, 19.4% after open vs 3.9% after laparoscopic operations, P < .001; grade II, 20.8% after open vs 8.4% after laparoscopic operations, P < .001), and 55% were wound related. Grades III and IV complications occurred in only 4 patients (1%), and frequency was similar for open and laparoscopic cases. Three factors were independently predictive of complications: diabetes mellitus (odds ratio [OR], 1.9; 95% confidence interval [CI], 1.1-3.3; P = .02), early surgeon experience (OR, 2.5; 95% CI, 1.4-4.2; P = .001), and open approach (OR, 3.9; 95% CI, 2.1-7.3; P < .001). CONCLUSIONS: Complications occurred in 18.3% of patients, but 95% were treated without leading to lasting disability. Presence of diabetes, early surgeon experience, and an open approach are risk factors of complications.

Update on bariatric surgical procedures and an introduction to the implantable weight loss device: the Maestro Rechargeable System.

There are many different methods of treating obesity, ranging from various medical options to several surgical therapies. This paper briefly summarizes current surgical options for weight loss with a focus on one of the newest US Food and Drug Administration-approved devices for surgical weight loss therapy, the Maestro Rechargeable System. Also known as the vagal blocking for obesity control implantable device, this tool blocks vagal nerve activity to induce weight loss.

The EMPOWER study: randomized, prospective, double-blind, multicenter trial of vagal blockade to induce weight loss in morbid obesity.

BACKGROUND: Intermittent, reversible intraabdominal vagal blockade (VBLOC® Therapy) demonstrated clinically important weight loss in feasibility trials. EMPOWER, a randomized, double-blind, prospective, controlled trial was conducted in USA and Australia. METHODS: Five hundred three subjects were enrolled at 15 centers. After informed consent, 294 subjects were implanted with the vagal blocking system and randomized to the treated (n = 192) or control (n = 102) group. Main outcome measures were percent excess weight loss (percent EWL) at 12 months and serious adverse events. Subjects controlled duration of therapy using an external power source; therapy involved a programmed algorithm of electrical energy delivered to the subdiaphragmatic vagal nerves to inhibit afferent/efferent vagal transmission. Devices in both groups performed regular, low-energy safety checks. Data are mean ± SEM. RESULTS: Study subjects consisted of 90 % females, body mass index of 41 ± 1 kg/m(2), and age of 46 ± 1 years. Device-related complications occurred in 3 % of subjects. There was no mortality. 12-month percent EWL was 17 ± 2 % for the treated and 16 ± 2 % for the control group. Weight loss was related linearly to hours of device use; treated and controls with ≥ 12 h/day use achieved 30 ± 4 and 22 ± 8 % EWL, respectively. CONCLUSIONS: VBLOC® therapy to treat morbid obesity was safe, but weight loss was not greater in treated compared to controls; clinically important weight loss, however, was related to hours of device use. Post-study analysis suggested that the system electrical safety checks (low charge delivered via the system for electrical impedance, safety, and diagnostic checks) may have contributed to weight loss in the control group.